An interventional study of individualized Transcranial Magnetic Stimulation in Post-Traumatic Stress Disorders, sponsored by 72nd Medical Group, Tinker Air Force Base. Terminated at 1 site in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2020-01-02.
Sponsored by 72nd Medical Group, Tinker Air Force Base · Not applicable, Interventional, and Treatment
After 13 years of war, PTSD has become pervasive in service members. Traditionally it is evaluated by PTSD Checklist Military Version (PCL-M) and treated with cognitive processing therapy, prolonged exposure therapy and medication management with limited success. Repetitive Transcranial Magnetic Stimulation (TMS) has shown efficacy for improving individual cognitive function in the past decades, both in healthy population and in patients with depression. TMS has been approved by the FDA in treatment of major depressive disorder and migraine headaches. Magnetic EEG guided Resonant Treatment (MeRT) is a form of individualized TMS based on member's EEG/ECG input. Investigators propose to use MeRT to treat veterans with war-related PTSD, a syndrome that includes depressive and anxious symptoms; it is likely that MeRT (namely TMS) will be beneficial and comparable to or better than the current FDA approved methods for treating PTSD.
1,147 studies on the registry are indexed under Stress Disorders, Traumatic; 108 are open to participants now.
This study's enrollment of 13 is below the median of 60 across 908 interventional studies indexed under Stress Disorders, Traumatic.
Browse Stress Disorders, Traumatic studies →This is the only study on the registry with 72nd Medical Group, Tinker Air Force Base as lead sponsor.
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Exclusion Criteria:
Individuals diagnosed by the Investigator with the following conditions (current unless otherwise stated):
Individuals with a clinically defined neurological disorder including, but not limited to:
The double-blind is used during the first 2 weeks. From week 3 and on, the study becomes open label. Subjects in Group I (active MeRT treatment group) will continue receive active MeRT treatment for W3/4; subjects in Group II (placebo/sham group) will receive active MeRT treatment from W3 to W6 for 4 weeks. All subjects will receive 4 weeks active MeRT treatment. The study ends in 8th wk. The data collection points are baseline, weeks of 2, 4, 6, and 8. The data from weeks 1-2 (Phase I) will be utilized to analyze the safety and any effect of MRT procedure may have over placebo. The data from weeks 3 on (Phase II) will be used to address if any benefit of longer MeRT treatment (4 vs 2 weeks). The study design offers both groups 4 weeks of the experimental therapy in a row. This will provide potentially equal benefit to those participants assuming that MeRT helps to improve PTSD symptoms.
Device: individualized Transcranial Magnetic Stimulation
The double-blind is used during the first 2 weeks. From week 3 and on, the study becomes open label. Subjects in Group I (active MeRT treatment group) will continue receive active MeRT treatment for W3/4; subjects in Group II (placebo/sham group) will receive active MeRT treatment from W3 to W6 for 4 weeks. All subjects will receive 4 weeks active MeRT treatment. The study ends in 8th wk. The data collection points are baseline, weeks of 2, 4, 6, and 8. The data from weeks 1-2 (Phase I) will be utilized to analyze the safety and any effect of MRT procedure may have over placebo. The data from weeks 3 on (Phase II) will be used to address if any benefit of longer MeRT treatment (4 vs 2 weeks). The study design offers both groups 4 weeks of the experimental therapy in a row. This will provide potentially equal benefit to those participants assuming that MeRT helps to improve PTSD symptoms.
Device: individualized Transcranial Magnetic Stimulation
Also known as: EEG-GUIDED MAGNETIC RESONANT THERAPY (MeRT)
The outcome will be measured by PTSD checklist -- military version (PCL-M) scoring criteria for PTSD. The outcome is measured additionally by Cognitive and Physical Functioning Questionnaire (CPFQ) for cognitive function improvement among the subjects.
The change of PCL-M and CPFQ scores from baseline and at weeks of 4 and 8 are assessed.
Time frame: At the end of week of 4 and 8.
Plan to share: Yes
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This study is terminated, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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